Stelex Company
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Stelex Employees
Shire Pharmaceuticals April 2012 - October 2012
Pfizer January 2009 - October 2011
EMC 2008 - 2008
Stelex 2002 - 2008
DOCWAVE 2001 - 2002
McLaren Consulting 1999 - 2001
Bentley Systems 1996 - 1999
Skills
Computer System..., Team Leadership, Leadership, Document Management, SDLC, Documentum, Project Management, Business Analysis, 21 CFR Part 11, Program Management, Integration, Cross-functional Team...
Education
Drexel University LeBow School of Business
Executive Certificate, eCommerce Management
University of Pittsburgh
Bachelor of Science (B.S.), Mechanical Engineering
Stryker January 2015 - Present
BD September 2011 - January 2015
BD August 2010 - September 2011
BD October 2006 - August 2010
BD November 2001 - October 2006
Oracle August 2000 - November 2001
BioMatrix May 1999 - August 2000
Stelex 1997 - 1998
Skills
Portfolio Management, Program Management, Sarbanes-Oxley, Validation Engineering, Global Application..., IT Transformation, Global Organizational..., Six Sigma, Process Improvement, FDA GMP, Quality Management, Software Quality..., ERP Implementations, Testing Services, Leadership Development, Project Management, Strategy Execution, Product Lifecycle..., LIMS, Document Lifecycle..., Vendor Management, SAP ERP, Talent Management, Quality Systems Design, Full SDLC, Continuous Improvement, Metric Management, SAP, SDLC, ERP, FDA, Integration, Cross-functional Team..., Design Control, Quality Auditing, 21 CFR Part 11, ISO 13485, Change Management, Strategy, ISO, Testing, PMO
Education
Rutgers University 1993 — 1997
Bachelor of Arts (B.A.), Biology, General
University of Scranton 1991 — 1993
TEKsystems 2012 - Present
Health Alliance Medical Plans April 2012 - November 2012
NetherRealm Studios October 2010 - March 2012
Volition, Inc. (THQ, Inc.) 2007 - 2010
Freelance August 2006 - January 2007
Wyeth March 2006 - July 2006
Freelance June 2005 - March 2006
Stelex April 2004 - October 2005
Radian Guaranty April 2003 - March 2004
D&D Interactive March 2001 - April 2003
Skills
Lua, ActionScript, Web Design, Graphic Design, Game Development, Flash, Photoshop, Illustrator, Fontography, Typography, Javascript, Crispy Links, Hardcore Gamer, Luxology modo, Maya, User Experience, Usability Testing, Information Architecture, Wordpress, CSS3, HTML5, jQuery, 3D Rendering, Hard Surface Modeling, Video Games, JavaScript, User Interface Design, User Interface
Education
Blackhawk College 1998 — 1999
Some College, Art, Art Multimedia, Art History
Minneapolis College of Art and Design 1996 — 1997
Some College, Drawing, Screen Printing
Edgewater Consulting February 2015 - Present
HyperTeam USA Business and IT Consulting, Inc. October 2014 - February 2015
ProPharma Group February 2013 - April 2014
Logixx Corp December 2008 - February 2013
QPharma, Inc February 2009 - December 2009
QAD 2008 - 2009
Stelex February 2004 - February 2008
Magnum 2000 - 2004
Purolator USA 1996 - 2000
Skills
Sales Leader, Sales Management, Operations Management, Management, Strategy, Partnerships, SaaS, Business Development, Medical Devices, Cross-functional Team..., Account Management, Start-ups, Pharmaceutical Industry, Solution Selling, Leadership, Sales Operations, New Business Development, Teamwork, Salesforce.com, Team Building, CRM, Consulting, Sales
Education
Stelex University 2005 — 2006
Risk Assessment and Remediation
Northeastern University 1987 — 1990
BS, Finance
Zimmer November 2008 - Present
Maetrics, LLC October 2006 - November 2008
Boston Scientific October 2006 - December 2007
Allergan 2005 - 2006
Stelex 2004 - 2006
Ethicon 1995 - 2004
Skills
V&V, Medical Devices, Validation, LIMS, Process Improvement, Continuous Improvement, Management, SPC, Computer System..., FDA, Quality System, ISO 13485, CAPA, GMP, Manufacturing, 21 CFR Part 11, Sop, Quality Assurance, Change Control, FMEA
Education
Angelo State University 1999 — 2002
BBA, Management Information Systems
Texas Tech University 1996 — 1997
Electrical Engineering/Computer Science
Weil Group, Inc. June 2010 - Present
Stelex August 2008 - May 2010
Patni Lifesciences and Taratec Development Corp. February 2004 - July 2008
Taratec Development Corporation October 2002 - January 2004
Baxter International Inc. August 1992 - May 2002
United States Air Force January 1984 - June 1992
Skills
21 CFR Part 11, Computer System..., FDA, Validation, CAPA, MES, SDLC, GMP, Change Control, V&V, Software Documentation, LIMS, Sop, Cross-functional..., Cross Functional Team..., System Testing, Quality System, Quality Assurance, GAMP, Systems Analysis, SOP
Education
University of Puerto Rico-Mayaguez 1978 — 1983
Bachelor of Science (BS), Biology, General
University of Puerto Rico-Mayaguez 1978 — 1983
BS, Biology, General
A.D.Ornamentals August 2012 - Present
n/a-freelance January 2008 - Present
Terminix January 2005 - July 2008
ives equipment January 2002 - June 2003
Stelex January 1996 - November 2001
Ethicon, Inc. January 1995 - September 1997
Intnl Micro Industries (I.M.I.) January 1993 - July 1994
CSC - Computer Sciences Corporation January 1990 - June 1991
Stone & Webster Engineering Corporation January 1979 - December 1987
Skills
Public Speaking, Books, Copy Editing, Editing, Creative Writing, Storytelling, Public Relations, Fiction Writing, Research, Journalism, Fiction, sculpture, portraiture, Portrait Sculpture, Program Management, Sculpture, Management, Grant Writing
Education
Drexel University 1990 — 1992
Master's Degree, Information Technology
Indiana University Bloomington 1969 — 1971
Master's Degree, Turkic, Uralic-Altaic, Caucasian, and Central Asian Languages, Literatures, and Linguistics, 4
Indiana University Bloomington 1967 — 1970
Bachelor's Degree, Cultural Anthropology
Temple University 1966 — 1968
History, Anthropology
Quintiles August 2014 - Present
Deloitte January 2011 - August 2014
Octagon Research Solutions March 2008 - October 2010
Stelex, Inc. October 2006 - March 2008
Stelex January 2001 - September 2006
Stelex August 1992 - December 2000
IBM 1989 - 1992
Skills
FDA, SDLC, Validation, Team Building, 21 CFR Part 11, Quality Systems, GMP, Computer System..., Document Management, Quality Assurance, Compliance, Business Process..., Pharmaceuticals, Program Management, GxP, Auditing, Life Sciences, Quality System, Pharmaceutical Industry, Six Sigma, Quality Auditing, Software Documentation, Lifesciences, Sop, Change Control, CRM, Enterprise Software, ERP, SOP
Education
Stevens Institute of Technology
BE, Mechanical Engineering
New Jersey Institute of Technology
MS, Management Engineering
Carrier Class Green Infrastructure March 2012 - July 2012
Aequor Technologies October 2010 - December 2011
EXTEDO Life Science Solutions June 2009 - March 2010
Idea Integration July 2006 - April 2008
Stelex 2004 - 2006
Sai People Solutions 2003 - 2004
Zaituna 2001 - 2002
Princeton Information 1997 - 2001
TACT 1994 - 1996
Skills
CRM, Strategy, Business Development, Management, Cross-functional Team..., Business Analysis, Quality Assurance, Leadership, Enterprise Software, Vendor Management, Start-ups, Sales, Integration, Contract Negotiation, Sales Operations, Business Planning, IT Service Management, Outsourcing, Recruiting, Project Management, Business Process, Sales Process, Program Management, SaaS, Cloud Computing, Solution Selling, Global Account...
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor’s Degree, Political Science and Government
Moorestown High School
Johnson & Johnson June 2012 - Present
Pfizer July 2011 - June 2012
Pfizer May 2010 - May 2011
Pfizer September 2008 - May 2010
Wyeth Pharmaceuticals 2008 - October 2009
TEKsystems January 2005 - September 2008
Stelex 2001 - 2002
Skills
GxP, 21 CFR Part 11, Change Control, Validation, Computer System...
Education
La Salle University 1990 — 1994
BA, Elementary/Special Education
Biogen January 2015 - Present
Novartis Vaccines and Diagnostics October 2012 - January 2015
Eisai June 2007 - October 2012
Stelex October 2004 - May 2007
Mintanciyan Consulting October 2000 - September 2004
Safety-Kleen November 1998 - October 2000
Skills
Computer System..., Validation, CAPA, Sop, Change Control, Quality Assurance, Software Documentation, Testing, GCP, 21 CFR Part 11, SDLC, GxP, FDA, GAMP, GMP, Pharmaceutical Industry, Quality System, LIMS, Regulatory Affairs, Biotechnology, V&V, Medical Devices, Quality Auditing, CRO, Auditing, Biopharmaceuticals, CTMS, Aseptic Processing, Clinical Development, Clinical Trials, Document Management, IND, ISO, Lifesciences, Pharmacovigilance, Protocol, Quality Control, Quality Management, Regulatory Requirements, Regulatory Submissions, SOP, Trackwise, Vaccines
Education
Universidad de Puerto Rico 1993 — 1998
Bachelor in Science
AliTek Consulting October 2013 - Present
Celgene July 2012 - October 2013
Stelex May 2000 - July 2012
Skills
OpenText Content Server, Livelink, OpenText Capture Center..., OScript, SDLC, Enterprise Architecture, Oracle, Software Development, Requirements Analysis, Software Project..., Integration, Enterprise Content..., Microsoft SQL Server, Software Engineering
Education
National Technical University of Ukraine 'Kyiv Polytechnic Institute' 1989 — 1995
Master's degree, Applied Mathematics and Computer Science
Johnson Matthey May 2011 - Present
Ulticom March 2001 - July 2011
Stelex February 1999 - March 2001
The Lehigh Press, Inc. January 1991 - January 1999
Safeguard Business Systems January 1989 - January 1991
GlaxoSmithKline June 1987 - December 1988
Skills
Iso 9000, MS Project, ClearCase, Process Optimization, Team Leadership, Software Development, Visio, FDA, 21 CFR Part 11, Root Cause Analysis, Quality Auditing, DMAIC, Agile Methodologies, Program Management, Testing, Process Simulation, Lean Manufacturing, GMP, Continuous Improvement, Validation, Quality Assurance, ISO, Project Management, Six Sigma, Software Project..., Cross-functional Team..., Requirements Analysis, Scrum, Quality Management, SPC, Quality Control, Integration, Oracle, Process Engineering, Telecommunications, Software Documentation, Management, Technical Writing, Design of Experiments, Quality System, Business Process..., Training, Medical Devices, Process Improvement, Minitab, ISO 13485, CAPA, TQM, FMEA, CMMI
Education
Drexel University - College of Business and Administration 1980 — 1982
MBA, Operations Management & Computer Systems
Penn State University
BA, Communications
Risetime April 2014 - Present
United3 Services, Inc. December 2008 - March 2014
TransAccel Group February 2011 - March 2012
Stelex September 2006 - January 2011
Nanavati Consulting, Inc. 2002 - 2007
Produce Marketing Association 1998 - 2002
United States Navy 1994 - 1997
MBNA 1992 - 1994
Skills
Enterprise Content..., Livelink, Business Analysis, Windows Server, SharePoint, System Deployment, Microsoft Exchange, Business Process, Enterprise Architecture, Business Intelligence, Content Distribution..., Business Process..., Integration, Network Architecture, VMware, Architecture, Content Management, Disaster Recovery, Infrastructure, Microsoft Technologies, Strategy, Cloud Computing, Virtualization, System Administration, IT Strategy, IT Management, Microsoft Certified..., Microsoft SQL Server, Windows Server 2008, Windows Server 2003, Windows 7, F5 BigIP, EMC, NetApp, SQL Server 2000-2008, MCSE, Computer Hardware, Content Server, Veritas, SiteScope, Load Balancing, Workflow, Technical Analysis, Technical Training, Storage, Cisco, System Design, Troubleshooting, Digital Asset Management
Education
Delaware Technical and Community College 1998 — 2000
Computer Network Engineering
Naval Nuclear Power Training Command 1994 — 1995
N/A, Electronics/Nuclear Theory
Delaware State University 1993 — 1994
Computer Information Systems
Embree Household June 2001 - Present
Stelex January 1998 - June 2001
American Thermocraft July 1995 - June 1996
Education
University of Cincinnati 1990 — 1994
BS, Biology
MetaVis Technologies July 2008 - Present
Vital Path Inc June 2005 - June 2008
Stelex June 1998 - June 2005
Sunbay AG June 1996 - May 1998
Skills
Product Development, Content Management, Software Integration, Integration, CMS, Software Development, Product Management, Enterprise Architecture, EAI, Product Marketing, Application Development, Business Strategy, Competitive Analysis, System Design, Start-ups, Product Launch, Team Building, Product Strategy, Business Planning, Software Engineering, Distributed Systems, SharePoint, Amazon Web Services, Cloud Computing, Enterprise Content..., ECM, Document Management, Solution Architecture, Agile, Enterprise Software, System Architecture, SaaS, Application Architecture, Technical Architecture, Agile Project Management, Amazon Web Services..., Agile Methodologies, Software Project..., Requirements Analysis, Databases, Documentum, Web Applications, Scrum, SOA, .NET, Microsoft Office..., Software Design, Architecture, XSLT, IIS
Education
Taurida 'V. I. Vernadskiy' National University, Simferopol 1986 — 1992
Master, Mathematics
Tminus1 Creative February 2010 - Present
One Communications March 2009 - June 2009
Stelex June 2007 - December 2008
CSL Behring Biotherapies January 2006 - April 2007
Peck Marketing Group 2004 - 2006
Wyeth Pharmaceuticals March 2003 - August 2004
Global Crossing 2000 - 2001
AT&T 1984 - 2000
Skills
Account Management, Marketing Communications, Contract Negotiation, Product Management, Cross-functional Team..., Fundraising, Business Development, Sales, Marketing Strategy, Marketing, Integrated Marketing, Advertising, Direct Marketing, Management, Business Planning, Leadership, Strategic Partnerships, Business Strategy, Product Development, Telecommunications, Enterprise Software, Direct Sales, B2B, Email Marketing, CRM
Education
College of Saint Elizabeth 1984 — 1989
BS, Bus. Admin. & Marketing
Stevens Institute of Technology
Masters Certification, Project Management
Papillon Aesthetics, LLC February 2015 - Present
Avanti Complex, Inc. January 2005 - Present
Acuity Systems LLC May 2015 - June 2015
AliTek Consulting June 2013 - February 2015
L Brands 2010 - June 2013
Stelex 2008 - June 2009
BearingPoint 2005 - January 2008
Arcata Assoc./NASA Dryden Flight Research Center 2004 - 2005
Sparta Inc./NASA Dryden Flight Research Center 2001 - 2004
NASA Ames Research Center 1998 - 2002
Skills
Opentext Content Server..., SharePoint, Business Process, SOA, Microsoft SQL Server, Enterprise Content..., Business Analysis, Project Management, Enterprise Architecture, Architecture, ERP, XML, Consulting, Requirements Analysis, Management, Enterprise Software
Education
University of South Florida 1982 — 1984
BA, International Studies, Brazilian Studies
University of South Florida
Bachelor's degree, International Studies
Medidata Solutions August 2014 - Present
Medidata Solutions May 2008 - Present
Medidata Solutions June 2005 - April 2008
Stelex August 2002 - June 2005
Interpec Corporation May 2001 - February 2002
Skills
Agile Methodologies, SDLC, Test Automation, SQL, Software Quality..., Software Project..., Scrum, Testing, Quality Assurance, Test Planning, Agile Project Management, Software Documentation, System Testing, User Acceptance Testing, Requirements Analysis, Integration, Project Management, Software Development, Management, HTML, Quality Center, Manual Testing, Test Cases
Education
Stevens Institute of Technology 1997 — 2002
Bachelor of Engineering (BE), Computer Engineering
Aurea Software 2014 - Present
NextDocs 2014 - Present
Invensys Operations Management 2008 - 2014
Stelex 2004 - 2008
Julian Management 2002 - 2004
Thermo Fisher Scientific (Apogent) March 2000 - December 2002
Signature Mortgage Group December 1998 - March 2000
Thermo Fisher Scientific December 1993 - December 1998
Skills
Solution Selling, Strategy, Biotechnology, Product Management, Sales, Manufacturing, Business Development, Medical Devices, Strategic Planning, B2B Marketing Strategy, Lifesciences, New Business Development, Process Automation, Process Control, Life Sciences, B2B, MES, Automation, Enterprise Software, Process Engineering, Selling Skills, DCS
Education
Bowling Green State University 1988 — 1993
B.A., Communications and Marketing
B. Braun Medical April 2010 - Present
Reed Technology February 2007 - March 2009
Stelex June 2002 - March 2006
Telcordia Technologies August 1980 - November 2001
Skills
Validation, Visio, Quality Assurance, Cisco Technologies, Medical Devices, FDA
Education
Stevens Institute of Technology 1985 — 1988
Johnson & Johnson September 2012 - Present
Azzur Group 2014 - 2014
Siemens Healthcare March 2012 - August 2012
Medimedia, USA April 2008 - February 2012
IPS July 2007 - April 2008
MediMedia USA September 2005 - June 2007
Stelex 2000 - 2005
Skills
Quality Assurance, 21 CFR Part 11, Validation, Business Process, Requirements Gathering, Change Control, Project Management, CAPA, Team Leadership, Software Documentation, Program Management, Medical Devices, Process Improvement, Computer System..., Requirements Analysis, Siebel, Oracle, Cross-functional Team..., SQL, FDA, GxP, Integration, Pharmaceutical Industry, SDLC, Visio, GMP, Software Quality..., Business Analysis, LIMS, Process Engineering, SharePoint, Testing
Education
Drexel University 1998 — 2001
Master's degree, Information Systems
Drexel University 1991 — 1996
Bachelor of Science (BS), Biology
Dynamics EAM Inc. 2011 - Present
Vital-Path Inc 2008 - 2011
Stelex 2000 - 2008
Skills
Enterprise Software, Document Management, FDA, Product Management, Cross-functional Team..., SDLC, SharePoint, Enterprise Content..., SaaS, Validation
Education
Kiivs'kij Deržavnij Universitet Tehnologij ta Dizajnu
Deloitte & Touche April 2007 - Present
Stelex January 2003 - April 2007
FPS 1997 - 2000
Skills
ERP, Process Improvement, Business Process..., Project Management, Consulting, Business Analysis, Quality Assurance, Management, IT Strategy, Program Management
Education
Eastern Michigan University 2000 — 2003
Masters, Infromation Technology
Siva Sivani Institute of Management 1997 — 1999
MBA, Business Administration
CenturyLink Technology Solutions 2006 - Present
Abbott Labs July 2006 - November 2007
Stelex 2002 - 2006
Skills
21 CFR Part 11, Validation, Computer System..., SOP, GxP, Compliance, Auditing, SDLC, Internal Audit, GAMP, Quality Systems, Quality Management, FDA, Change Control, cGMP, GMP, CAPA, Quality Assurance, Document Management, Software Validation, Documentation, IT Audit, Validations, Compliance Audits, Compliance Management, Vendor Management, ITIL, Process Improvement, Quality System, Quality Auditing, Business Continuity, Disaster Recovery, IT Service Management, Software Documentation, Sop, Leadership, Data Center, Information Technology, Information Security, Governance, IT Outsourcing, ISO 27001, Business Process, Information Security..., Incident Management, IT Strategy, CISSP, IT Management, Infrastructure, IT Operations
Education
New Jersey Institute of Technology 1992 — 1996
Bachelor of Science (BS), Electrical and Electronics Engineering
Bristol-Myers Squibb Co. June 2008 - Present
Bristol-Myers Squibb Co. September 2004 - June 2008
Stelex 2001 - 2003
First Consulting Group September 1998 - October 1999
Nortel Networks January 1997 - September 1998
FP Integration January 1993 - December 1996
Rancocas & Zurbrugg Hospitals (Graduate Health System) 1989 - 1993
Skills
Computer System..., Change Control, Pharmaceutical Industry, Project Management, Vendor Management, SDLC, IT Service Management, ITIL, Management, Validation, Cross-functional Team..., Software Documentation, IT Strategy, Disaster Recovery, Project Portfolio..., Quality Assurance, Service Delivery, IT Management, Process Improvement, SharePoint, PMP, Business Process, Business Process..., Resource Management, Change Management, Program Management, Integration
Education
Penn State University 2015 — 2017
Lockheed Martin July 2008 - Present
Alcon January 2003 - June 2008
Stelex 2001 - 2003
MedAI 2000 - 2001
bioMerieux 1999 - 2000
Mallinkrodt 1989 - 1999
Skills
Quality System, CAPA, Quality Assurance, FDA, Testing, Quality Control, GMP, Cross-functional Team..., Software Quality..., Product Development, Validation, Iso 9000, Project Management, ISO 9000, Root Cause Analysis, Software Development
Education
Florida Institute of Technology 2009 — 2011
Master of Science (M.S.), Information Technology, 3.98
University of Phoenix 2004 — 2007
BSIT, Computer Information Systems - with Honors
St. Louis Community College
AS, Quality Control Technology
LT BioPharma Consulting December 2007 - Present
Hospira January 2012 - June 2013
CorePharma LLC October 2011 - January 2012
Hill Dermaceuticals, Inc. September 2008 - June 2011
Nephron Pharmaceuticals 2008 - 2008
Washington Group International October 2001 - October 2007
GSK 2005 - 2006
Stelex 2000 - 2002
Pharmacia & Upjohn 2000 - 2002
Bayer Corporation 1999 - 2000
Education
North Carolina State University 1993 — 1998
BS, Biology
Paragon Solutions, Inc. January 2015 - Present
Synthes August 2014 - December 2014
Paragon Solutions, Inc. April 2009 - July 2014
Wyeth Pharmaceuticals May 2007 - February 2009
Centocor July 2006 - March 2007
Bristol-Myers Squibb May 2002 - July 2006
RadPharm February 2001 - May 2002
Merck February 2000 - February 2000
Stelex 1998 - 2000
Argus Research August 1997 - May 1998
Skills
Software Documentation, Computer System..., 21 CFR Part 11, Quality Assurance, System Testing, Requirements Analysis, Change Control, Data Migration, Testing, Clinical Trials, CTMS, Sop, Document Management, SDLC, Validation, User Acceptance Testing, Integration, Business Analysis, Test Management, SharePoint, FDA, CAPA, Pharmaceutical Industry, GMP
Education
Villanova University
Master of Business Analysis - Certificate
Michigan State University
B.S., Psychology, Science
BMS January 2015 - Present
Bristol-Myers Squibb June 2010 - December 2014
Bristol-Myers Squibb September 2006 - June 2010
Bristol-Myers Squibb February 2004 - September 2006
Stelex May 2002 - February 2004
Advertisting Specialty Institute November 1998 - May 2002
Skills
Validation, Quality Assurance, Change Control, SDLC, Computer System..., 21 CFR Part 11, FDA, GMP, Software Documentation, Testing, Process Improvement, Auditing, Sop, Internal Audit, IT Management, GxP, Troubleshooting, Sarbanes-Oxley Act, Sarbanes-Oxley, SOP
Education
La Salle University 2005 — 2007
M.S., IT
La Salle University 1992 — 1997
Axendia, Inc. 2005 - Present
Leadership Systems, Inc. January 1998 - Present
Stelex February 2005 - October 2005
Stelex December 1998 - February 2005
Johnson & Johnson January 1996 - January 1998
Johnson & Johnson January 1993 - January 1996
Johnson & Johnson January 1991 - January 1993
Johnson & Johnson January 1989 - January 1991
Johnson & Johnson January 1987 - January 1989
Johnson & Johnson January 1979 - January 1988
Skills
Medical Devices, Validation, Quality Assurance, FDA, Quality Systems, Program Management, Team Building, Product Development, Business Strategy, Change Management, Compliance, Quality System, Business Process..., Quality Management, GMP, Regulatory Affairs, Lifesciences, Strategy, Cross-functional Team..., ISO 13485, Manufacturing, Pharmaceutical Industry, Life Sciences
Education
Bellevue University
M.A, Leadership
Rutgers University
B.S, Management
Merck & Company 2011 - Present
Merck September 2008 - 2011
Indevus Pharmaceuticals, Inc. (Formerly employed by Valera Pharm.) August 2006 - June 2008
Schering-Plough Pharmaceuticals June 2005 - August 2006
Schering-Plough Pharmaceuticals April 2003 - June 2005
Wyeth June 2001 - April 2003
Stelex June 1999 - May 2001
Carter-Wallace Inc. September 1990 - October 1998
Skills
Quality System, Program Management, Cross-functional Team..., Regulatory Affairs, Project Management, Pharmaceutical Industry, GMP, Budgets, Vaccines, CAPA, SDLC, Quality Assurance, MS Project, Technology Transfer, Strategy, 21 CFR Part 11, Validation, Business Process..., Biotechnology, Process Improvement, Six Sigma, Leadership, FDA, Change Control, Computer System..., GxP, Sop, Medical Devices, Drug Development, Regulatory Submissions, SOP, Team Leadership, Clinical Development, Biopharmaceuticals
Education
Monmouth University 1984 — 1989
MBA
Erskine College 1972 — 1976
BA, Biology
Pfizer December 2006 - Present
Stelex October 1998 - December 2006
Skills
Pharmaceutical Industry, 21 CFR Part 11, Validation, Change Control, FDA, Clinical Development, GMP, Sop, Leadership, Biotechnology, Regulatory Affairs, Quality Assurance, Quality System, GLP, Computer System..., CAPA, Medical Devices, GCP, Regulatory Submissions, Lifesciences, Management, Biopharmaceuticals, V&V, Drug Development, Technology Transfer, CRO, Clinical Trials, Document Management, Quality Auditing
Education
Temple University 2014 — 2017
Master of Science (MS), Quality Assurance / Regulatory Affairs
Delaware Valley University 1991 — 1995
BS, Chemistry
Stay at home mom May 2011 - Present
Abbott Vascular Devices January 2011 - May 2011
Abbott Vascular Devices July 2009 - January 2011
Abbott Vascular Devices July 2008 - July 2009
Stelex July 2001 - July 2008
Merck January 2000 - July 2001
Skills
V&V, Validation, FDA, GMP, ISO 13485, Change Control, CAPA, 21 CFR Part 11, Design Control, Sop, Quality System, Design of Experiments, Computer System..., Technology Transfer, Medical Devices, Pharmaceutical Industry, Quality Assurance, Cross-functional Team..., SOP, Management, Manufacturing
Education
Université Blaise Pascal (Clermont-II) - Clermont-Ferrand 1998 — 1999
DESS, Quality
Université Blaise Pascal (Clermont-II) - Clermont-Ferrand 1997 — 1998
Master, Physics, chemistry
Quality Improvement Systems June 2014 - Present
Baxter June 2012 - June 2014
Zimmer/CIQA June 2011 - June 2012
Stelex November 2009 - January 2010
Applied Engineering Group November 2007 - November 2009
Quality Improvement Systems January 2002 - November 2007
Glaxo Smithkline November 1998 - October 2007
Skills
Infrastructure Planning, Web Design, Software Development, Pharmaceutical Industry, Engineering, Continuous Improvement, MES, Management, GAMP, Medical Devices, SAP, Security, GxP, Process Control, Document Management, Analysis, Integration, Training
Education
Universidad de Puerto Rico 1976 — 1980
BBA - IT System Analysis and Design, Minor Finance, BBA, Info Systems/Finance
Luis Munoz Rivera Sabana Grande Puerto Rico
High Scool, High School/Secondary Diplomas and Certificates
cGMP Validation January 2008 - Present
Pfizer 2002 - 2009
Stelex December 2006 - January 2008
Technisource June 2003 - November 2005
MetLife October 2000 - September 2001
Education
Western Michigan University - Haworth College of Business 2003 — 2005
MBA, Marketing
University of Connecticut 1997 — 2000
BS, Management Information Systems
RevSystems Inc. May 2004 - Present
Stelex 2002 - 2004
Electric Mobility Corporation 1999 - 2001
Stabilus 1996 - 1999
Electronic Data Systems 1985 - 1996
Skills
Project Management, SDLC, Change Management, Program Management, Six Sigma, Software Development, Integration, Software Project..., Quality Assurance, PMP, Business Development, PMO, IT Strategy
Education
DeVry University 1983 — 1985
Bachelor of Science, Electronics Engineering
Datascope January 2000 - Present
Stelex 1997 - 1999
Skills
Biomedical Engineering, Medical Devices, Embedded Systems, V&V, Debugging, Validation, ClearCase, Software Engineering, Embedded Software, C++, Design Control, R&D, Testing, UML, Software Design, ClearQuest, ISO 13485, Firmware, TCP/IP, Labview, Software Development
Education
Penn State University 1994 — 1995
Master of Science (M.S.), Electrical and Electronics Engineering
Stevens Institute of Technology 1993 — 1994
Master of Engineering (M.Eng.), Electrical and Electronics Engineering
Stevens Institute of Technology 1990 — 1993
Bachelor of Engineering (B.Eng.), Computer Engineering
Discovery Labs July 2001 - Present
Stelex February 2001 - April 2001
Stelex June 2000 - January 2001
Stelex August 1998 - April 2000
Skills
Validation, Pharmaceutical Industry, Quality Assurance, Sop, FDA, Software Documentation, Aseptic Processing, Quality System, GLP, Biotechnology, GMP, Computer System..., 21 CFR Part 11, Biopharmaceuticals, CAPA, Change Control, Clinical Development, Clinical Monitoring
Education
Temple University 1974 — 1978
BA
St. Jude Medical June 2013 - Present
Boston Scientific December 2006 - September 2012
Stelex June 2005 - December 2006
Pfizer June 2004 - June 2005
Brock Solutions May 1999 - June 2004
Skills
Computer System..., Validation Engineering, ISO 13485, Medical Devices, Validation, FDA, Quality System, Labview, Testing, FMEA, Quality Assurance, Design of Experiments, CAPA, GMP, V&V, Process validation, Software Validation, Software Documentation, Software Testing Life..., Test Automation, Commissioning, Engineering
Education
University of Phoenix 2010 — 2015
Bachelor of Science (BS), Information Technology / Software Engineering
Central Connecticut State University 2004 — 2008
Bachelor of Technology (B.Tech.), Electrical Engineering Technologies/Technicians
Sault College 1995 — 1999
Electrical Engineering Technologist Diploma, Electrical Engineering, Automation, PLC and HMI programming, etc.
Sault College 1995 — 1999
Instrumentation Technician Dipoloma, Instrumentation Technology/Technician
NASDAQ OMX July 2011 - Present
L-3 Communications May 2005 - July 2011
Stelex April 1998 - May 2005
Skills
C, Java, C#, 68k Assembly, ARM, Nios II, Microblaze, HCS12, PowerPC, OMAP, Linux, Linux Kernel, Windows, Microsoft SQL Server, Matlab, Embedded Systems, ITCH, Requirements Analysis, Unix, Integration, XML, Operating Systems
Education
Drexel University 2000 — 2002
MS, Computer Science
Drexel University 1997 — 1999
BS, Computer Science
Insmed September 2005 - Present
Transave Inc. 2008 - 2009
Schering-Plough Pharmaceuticals 2001 - 2005
Stelex 2000 - 2005
Liposome 1987 - 1997
Skills
Quality Assurance, Validation, GMP, Computer System..., FDA, CAPA, 21 CFR Part 11
Education
Ewing
Rutgers University-New Brunswick
Nobel Biocare June 2013 - Present
Nobel Biocare April 2010 - June 2013
Stelex April 2004 - April 2010
Skills
Quality Assurance, Validation, Testing, FDA, Agile Methodologies, V, SDLC, Medical Devices, Quality System, Change Control, Software Project..., CAPA, Computer System..., GMP, 21 CFR Part 11, Documentum, Sop, Document Management, Pharmaceutical Industry, Change Management, GxP, Test Planning, System Testing, Cross-functional Team..., Maximo, JIRA, Regulatory Requirements, Test Cases, Regression Testing, Test Methodologies, GAMP, V&V
Education
New Jersey Institute of Technology 1998 — 2003
BS, Computer Engineering
McNeil Consumer Healthcare May 2011 - Present
McNeil Consumer Healthcare May 2011 - Present
Impact Systems, Inc. March 2009 - Present
Merck July 2010 - May 2011
Impact Systems, Inc March 2009 - July 2010
Pfizer Pharmaceutical Research Laboratories July 2008 - January 2009
CSC June 2007 - July 2008
Stelex October 2002 - June 2007
VerticalNet January 2000 - January 2001
Honeywell, Inc January 1991 - January 2000
Skills
Technical Writing, Validation, Quality Assurance, 21 CFR Part 11, SOP, Computer System..., Document Management
Education
Temple University - Fox School of Business and Management 1986 — 1992
MBA, Marketing
University of Notre Dame, Notre
BS, Chemical Engineering
University of Notre Dame 1975 — 1980
B.S., Chemical Engineering
Penn State University
Optimation September 2013 - Present
manufacturing client August 2013 - September 2013
manufacturing client June 2013 - June 2013
Maverick Technologies March 2011 - April 2013
Avanceon August 2010 - March 2011
Maverick Technologies 2009 - 2010
Program4 Engineering 2002 - 2009
Stelex 2001 - 2002
Sequel, Inc. 1995 - 2000
All-Control Systems 1990 - 1995
Skills
PLC Programming, HMI/GUI Development, Specification & Testing..., Allen-Bradley..., Specifications, Allen Bradley, PLC, Automation, Control Systems Design, SCADA, Wonderware, Process Control, Instrumentation, Process Automation, HMIs, DeviceNet, Commissioning, Control Logic, Human Machine Interface, Engineering
Education
University of Massachusetts Lowell 1976 — 1980
BSEE, Electrical Engineering
MENTOR Technical Group Corporation March 2013 - February 2014
VEG April 2012 - February 2013
Honeywell Aerospace September 2010 - April 2012
Kelly It Services/Lifescan Products October 2009 - August 2010
Techjobs International August 2007 - July 2008
Stelex September 2002 - December 2005
Abaco International Group January 1996 - August 2002
Orion International Technologies January 1995 - December 1995
COLSA October 1989 - December 1995
Skills
Systems Engineering, Software Engineering, Microsoft SQL Server, Oracle Database Server, Oracle PL/SQL..., Automation, Engineering, Validation, Commissioning, Oracle, Quality Assurance
Education
UPRM School of Engineering 1982 — 1988
BS, Computer Engineering
Universidad del Turabo 1992 — 1995
Master of Business Administration (MBA), Business Administration and Management, General
Bristol-Myers Squibb March 2014 - Present
Integrated Project Services (IPS) 2005 - February 2014
Stelex 2002 - 2005
Roche Molecular Systems 1998 - 2002
Skills
GMP, Validation, Pharmaceutical Industry, Change Control, Sop, GxP, FDA, 21 CFR Part 11, Computer System...
Education
Kutztown University of Pennsylvania 1993 — 1997
Bachelor of Science (BS), Marine Science
union highschool
Eli Lilly and Company March 2009 - Present
Eli Lilly and Company November 2006 - February 2009
Stelex September 2003 - October 2006
Pharmaplan.Flaval August 2001 - August 2003
Abaco Mobile June 1998 - July 2001
Skills
Computer System..., Computer Systems..., Network Administration, Cisco Wireless, Trackwise, CAPA, Document Management, Remedy AR System, Microsoft Office, CiscoWorks, Solarwinds, cGMP practices, 21 CFR Part 11, Sarbanes-Oxley, IT Audit, External Audit, Internal Audit, Standards Compliance, Cisco IOS, SOP development, Software Documentation, Integration, Validation, GMP, Six Sigma, Process Improvement, Management
Education
University of Puerto Rico-Mayaguez 1993 — 1998
Bachelor of Business Administration (B.B.A.), Computer and Information Sciences and Support Services